Fasting-mimicking Diet and Longevity Diet, Body Composition and Aging

Summary

This study was designed as a large, randomized, controlled clinical trial in a heterogeneous population and is aimed at assessing as a primary objective whether the fasting-mimicking diet alone or in combination with the longevity diet can modify the percentage of fat mass in a cohort of subjects stratified by sex, age and body mass index. As secondary objectives, will evaluate the effects of the fasting-mimicking diet alone or in combination with the longevity diet on the general health conditions of the population.

From a public health point of view, the efficacy of a food intervention such as the longevity diet and/or short periods of fasting-mimicking diet would represent proof of the results that can be achieved by a realistics, feasible and inexpensive approach.

The information obtained is relevant because the nutritional intervention will be undertaken by people who live in their normal environment and who simply receive every day dietary guidelines, and support and/or boxes containing a 5 day meal program to be consumed in lieu of their normal diet once every 3 months.

Conditions

• Overweight
• Risk Behavior
• Obesity

Interventions

BEHAVIORAL

Fasting-mimicking diet (FMD)

The subjects will be instructed to follow their usual diet plan, except for 5 days when they eat the foods in the FMD box.The fasting-mimicking diet consists of a blend of 100% plant based nutrients generally regarded as safe. The formulation of these products is based on studies carried out at the Longevity Institute of the University of Southern California and his collaborators over several decades of studies. This food plan provides for the replacement of the normal diet with the organic plant products contained in the fasting-mimicking diet for five consecutive days.

BEHAVIORAL

Longevity Diet (LD) + Fasting-mimicking Diet (FMD)

The subjects will be instructed to follow their longevity diet plan, except for 5 days when they eat the foods in the FMD box, based on the following guidelines: vegan based diet with the addition of low mercuryfish 2-3 times a week; protein content should be 0.7-0.8 grams per kilogram of ideal weight per day (most of the protein coming from whole cereals,vegetables, legumes and tree nuts only part from fish); monounsaturated and polyunsaturated fats are predominant and very low amounts of saturated and trans-fats are allowed; complex Carbohydrates from vegetables, whole grains and legumes; addition of vitamins, minerals and Omega3 fats; food selected between the traditional food consumed by ancestry; time-restricted feeding: all food must be consumed within 12 hours each day. for those who are overweight or are nearly overweight (BMI \>25 kg/m2), either lunch or dinner will be substituted with a low calorie, low sugar snack (approximately 100 kcal: salad, nuts, fruit, etc.).

Sponsors & Collaborators

• University of Calabria

  collaborator OTHER

• University of Palermo

  collaborator OTHER

• Regione Calabria / Comune Varapodio

  collaborator UNKNOWN

• IFOM ETS - The AIRC Institute of Molecular Oncology

  collaborator OTHER

• European Longevity Institute

  collaborator UNKNOWN

• Fondazione Valter Longo

  lead OTHER

Principal Investigators

• Romina Inès Cervigni · Fondazione Valter Longo

• Alberto Montesanto · Department of Biology, Ecology and Earth Sciences, University of Calabria

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-01-30

Primary Completion

2024-07-30

Completion

2025-01-30

Countries

• Italy

Study Locations